Magnetic Muscle Stimulation of Abdominal Muscle

Not Applicable

Terminated

• Conditions: Muscle Weakness

• Registration Number: NCT04199312
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

Evaluate the safety and efficacy of magnetic muscle stimulation (MMS) of abdominal muscle.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-13
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Results First Submitted: 2025-05-28
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Results First Posted: 2025-07-02
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Body Satisfaction Questionnaire From Baseline to 1-Month Post-Treatment Follow-up Visit	Baseline, 1-month post-treatment follow-up visit	Measurement of participant's perception about body shape, assessed using the Body Satisfaction Questionnaire (BSQ) at the 1-month post-treatment follow-up visit. The scale measures body image using a set of dichotomous items used to describe aspects of shape and appearance. The questionnaire has total score range from 10 to 50. An increase in score (when compared to baseline) reflects the participant's perceived improvement in appearance in the treated region (abdomen). Questionnaire results were tabulated as the numerical change between mean baseline scores and scores recorded at the 1-month post-treatment follow-up visit. A positive change reflects an increase in the body satisfaction questionnaire total score.
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)	AE information will be collected from the time of enrollment to the final follow-up visit at 3-months following the final treatment.	An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.

Trial Locations

Locations (3)

Investigate MD; 🇺🇸 Scottsdale, Arizona, United States

Innovation Research Center; 🇺🇸 Pleasanton, California, United States

Laser and Skin Surgery Center of Northern California; 🇺🇸 Sacramento, California, United States